Cleared Traditional

DRSplus

K192113 · Centervue S.P.A. · Ophthalmic
Nov 2019
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K192113 is an FDA 510(k) clearance for the DRSplus, a Ophthalmoscope, Laser, Scanning (Class II — Special Controls, product code MYC), submitted by Centervue S.P.A. (Padova, IT). The FDA issued a Cleared decision on November 15, 2019, 102 days after receiving the submission on August 5, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K192113 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2019
Decision Date November 15, 2019
Days to Decision 102 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MYC — Ophthalmoscope, Laser, Scanning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570